Spots Global Cancer Trial Database for Radiation Therapy With or Without Epoetin Alfa in Treating Patients With Head and Neck Cancer

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Trial Identification

Brief Title: Radiation Therapy With or Without Epoetin Alfa in Treating Patients With Head and Neck Cancer

Official Title: A Phase III Double-Blind, Randomized, Placebo-Controlled Study of Erythropoietin When Used as an Adjuvant to Radiation Therapy in Patients With Head and Neck Squamous Cell Carcinoma

Study ID: NCT00017277

Conditions

Head and Neck Cancer

Interventions

epoetin alfa

radiation therapy

Study Description

Brief Summary: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Epoetin alfa may help prevent or treat cancer-related anemia. It is not yet known whether radiation therapy is more effective with or without epoetin alfa in treating head and neck cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without epoetin alfa in treating patients who have head and neck cancer.

Detailed Description: OBJECTIVES: * Compare the efficacy of radiotherapy (in terms of local-regional control) with or without epoetin alfa in patients with squamous cell carcinoma of the head and neck. * Compare the disease-specific and overall survival of patients treated with these regimens. * Compare the hemoglobin level of these patients during radiotherapy. * Compare the acute and late toxic effects of these regimens in these patients. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to participating center, site of disease (larynx vs hypopharynx vs oropharynx vs oral cavity), T-classification (T1-2 vs T3-4), N-classification and intent of systematic neck node dissection (N0-1 vs N2-3 without node dissection vs N2-3 with node dissection), hemoglobin level and gender (men with 10-12.5 g/dL vs men with 12.5-14 g/dL vs women with 10-12 g/dL vs women with 12-13.5 g/dL), and type of treatment (EORTC standard vs other vs randomized in other trials). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients undergo standard radiotherapy 5 days a week and receive concurrent epoetin alfa subcutaneously (SC) once weekly. * Arm II: Patients undergo radiotherapy as in arm I and receive concurrent placebo SC once weekly. Treatment on both arms continues for 6-8 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed at 3-6 weeks and 9-14 weeks, every 3 months for 2 years, every 6 months for 1 year, and then annually thereafter. After any locoregional recurrence, patients are followed every 6 months for 1 year and then annually thereafter. PROJECTED ACCRUAL: A total of 800 patients will be accrued for this study within 3 years.